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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SEAL (4.5MM), 5-PACK CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HSK III SEAL (4.5MM), 5-PACK CLAMP, VASCULAR Back to Search Results
Model Number HST III SEAL (4.5MM), 5-PACK
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
Trackwise id # (b)(4). Since the device is not available to be returned to us, a technical evaluation cannot be performed. Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using hst iii seal (4. 5mm), 5-pack, they loaded the seal and inserted it into the aorta, but it was not properly deployed and they decided that it could not be used properly and gave up using it. Central anastomosis was performed with another device. There was no effect on the patient.
 
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Brand NameHSK III SEAL (4.5MM), 5-PACK
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer Contact
dorota wolpiuk
45 barbour pond drive
wayne, NJ 
MDR Report Key12023892
MDR Text Key261779797
Report Number2242352-2021-00481
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/15/2022
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberC-HS-3045
Device Lot Number25156894
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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